Hengelo, NL · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | 2 | 2026-03-16 |
| PGM | Growing Rod System | Class II | Orthopedic | 1 | 2026-01-15 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2021-09-14 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | 1 | 2020-08-27 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-16 | K254176 | SINEFIX | MBI | Class II | Orthopedic |
| 2026-01-15 | K251961 | SDS Growing Rod | PGM | Class II | Orthopedic |
| 2023-03-08 | K220966 | SINEFIX | MBI | Class II | Orthopedic |
| 2021-09-14 | K211474 | Kleiner KG2 System | MAX | Class II | Orthopedic |
| 2020-08-27 | K201830 | ANSER Clavicle Pin | HSB | Class II | Orthopedic |